Beyond Document Delivery: How a Compliance-First CER Strategy Helped Achieve a Successful Notified Body Review
Maurice Bancsi
23 Jun, 2025
Based in the Netherlands, Maurice has over 27 years’ experience in the pharmaceutical and biotech industry, mainly supporting pre-approval drugs and biologics for oncology, pulmonary and cardiovascular indications, with extensive experience in developing regulatory strategies, leading cross-functional teams in health authority interactions (Scientific Advice, both on national and EU level) regulatory intelligence and applications including document development to support applications such as MAAs, CTAs, EU & US Orphan Drug Applications, PIPs, iPSPs, IND Annual Reports and DSURs.
He holds a Master’s degree in Medical Biology from the University of Utrecht and a Doctorate in Medicines from the University of Leiden, Netherlands.
Other Related Articles
21 Jul, 2026
15 Jul, 2026
08 Jul, 2026
02 Jul, 2026
26 Jun, 2026
17 Jun, 2026